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MICROBIAL LIMIT TEST(MLT)

For non-sterile products, we can perform microbial contamination testing using harmonized pharmacopoeia or client-supplied methods to determine
the bio burden within the sample. The microbial examination of non –sterile products is done as under.
MICROBIAL EXAMINATION

Solution A Solution B

Specified Micro-organism EEB Total Viable Count incubate for 30-35


(SPMO) 10 mL Solution A+100mL EEB 1mL for TAMC For 24 hrs
10 ml Sample + 90 ml SCDM 1 mL for TYMC
Incubate Loop full 0.1 sample

E.coli Pseudomonas Staphylococcus 30-35’c for Bacteria fungi Inoculate on RVS


aeruginosa aureus 48 hrs

0.1 mL MacConkey Sol A Sol A Loopfull smaple 1ml of sample 1 Ml of sample Streak on XLDA
Broth+0.1 sample streak on streak on streak on +25ml of + 25ml of SDA after Incubation
Kept for 42-45’c/48 hrs CA MSA VRBGA SCDA of 30-5’c for 24 hrs

Loopfull sample Incubate 30-35’c Incubate 30-35’c Incubate 30-35’c Incubate 30-35’c Incubate for 20-25’c After incubation
Streak on MA for 72 hrs for 72 hrs for 24 hrs for 5 days for 7 days completed

30-35’C Incubate After incubation After incubation After incubation After incubation After incubation Result on
for 72 hrs completed completed completed completed completed colony counter

After incubation Result on Result on Result on Result on Result on Salmonella Absent


completed colony counter colony counter colony counter colony counter colony counter /1o ml

Result taken on pseudomonas Staphylococcus Entrobacter TRMC Absent/ TYMC Absent/


colony counter absent /ml absent /ml gram –ve Plate Plate

Ecoli absent /ml absent /ml